Director, Human Factors at AstraZeneca in Waltham, Massachusetts

Job Description:

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.


Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.


The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be responsible for the human factors engineering group. They will build strong relationships and collaborate with cross functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use.



Main Duties & Responsibilities:

• Lead Human Factors efforts for combination product and new technology development including ethnography, requirements definition research, formative studies, instruction and training development, risk analysis and summative studies.
  
  


• Write and review HF sections for health authority submissions.
  
  


• Interact with health authorities during face to face meetings and in written responses.
  
  


• Engage AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and standard processes.
  
  


• Manage HF engineers and mentor the group professionally.
  
  


• Be a voice of user centricity across all product types in AstraZeneca.
  
  


• Be engaged with and influence Human Factors standard processes externally across industry and with regulators
  
  


• Improving internal Human Factors processes to ensure consistency, compliance and efficiency
  
  

Education & Experience Requirements:



Degree in human factors engineering, mechanical engineering, bioengineering or related field is required. 10+ years' experience in combination product or medical device development, with at least 7 years focused on human factors engineering (HFE). They will have demonstrated the ability to support the HFE activities described above.



Required Skills:

• Strong depth of knowledge in Human Factors engineering including a working knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in this space
  
  


• Strong communication skills with an ability to influence internal partners as well as external industry and health authorities
  
  


• Ability to lead a global team, create a positive work environment and effectively develop staff
  
  

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


Why AstraZeneca?


We follow the science to explore and innovate, working towards treating, preventing, modifying and even curing some of the world's most complex diseases. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Here you will work with curious minds in an inclusive culture where all doors are open, every voice is heard, and we are forever expanding our horizons.


Ready to make an impact on patients' lives? Join us at AstraZeneca where we are pushing the boundaries of science to deliver life-changing medicines. Apply now!



Are you interested in working at AZ, apply today!



AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.


#LI-Hybrid


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now